Patent Foramen OvaleCAPPRESNCT05592301
Patent Foramen Ovale (PFO) and Risk of Perioperative Stroke
An observational study of Patent Foramen Ovale, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
This is a multi-centre, prospective cohort study to determine if asymptomatic PFO is a risk factor for developing perioperative overt and covert stroke in patients undergoing non-cardiac surgery. Read more about this study
- Who is it for?
- Ages 18 to 110 years
- Conditions the study is for
- Patent Foramen Ovale
- What is being tested?
- Diffusion-weighted Magnetic Resonance Imaging (DW-MRI), Transcranial Doppler (TCD) and Transthoracic Echocardiogram (TTE)
- How many people
- 408 participants
- Where
- 1 siteCanada
- Study dates
- 7 Jul 2023to 1 Jul 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 110 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients referred for an elective, non-cardiac, non-vascular and non-brain surgery
Who may be able to join
- patients 18 years and above;
- referred for an elective, non-cardiac, non-vascular and non-brain surgery;
- with an estimated hospital length of stay ≥2 days. We will include patients referred for general, orthopedic, urological, gynecologic, spinal or thoracic surgery.
Who cannot join
- patients in need for long-term, perioperative anticoagulants;
- those with comorbidities that potentially increase the risk of perioperative stroke;
- contraindications to MRI;
- unable to complete or adhere to the study.
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Toronto General Hospital, UHN
Toronto, Ontario
Lusine Abrahamyan, MD, 416-340-4800, lusine.abrahamyan@uhnresearch.ca
About this study
Official title: Canadian Patent Foramen Ovale and Perioperative Stroke Evaluation Study (CAPPRES): A Feasibility Study
This is a multi-centre, prospective cohort study to determine if asymptomatic PFO is a risk factor for developing perioperative overt and covert stroke in patients undergoing non-cardiac surgery.
Read the detailed description
There is emerging evidence regarding the increased risk of perioperative stroke in patients with PFO, leading to an important clinical practice question: whether PFO should be considered in the perioperative risk assessment in non-cardiac surgery patients. The evidence base, however, comes from retrospective studies with numerous limitations.
Patients referred for general, orthopedic, urological, gynecologic, spinal, or thoracic surgery will be screened and consented during the surgery pre-admission clinic visit, and then undergo PFO screening using transcranial Doppler (TCD) and transthoracic echocardiography (TTE). Patients screened PFO+ (n=102) and matched PFO- controls (n=102) will have DW-MRI between postoperative days 2 and 7. Study personnel will conduct phone surveys at 30-day and 1-year post-surgery to collect data on other clinical outcomes. Patients will also be administered cognitive and patient-reported outcome measures assessments before enrollment, and 30-day and 1-year follow-up.
- Conditions
- Patent Foramen Ovale
- Being tested
- Diffusion-weighted Magnetic Resonance Imaging (DW-MRI), Transcranial Doppler (TCD), Transthoracic Echocardiogram (TTE)
- Keywords
- Patent Foramen Ovale, Perioperative Stroke, Diffusion-weighted Magnetic Resonance Imaging
- Medical subject headings
- Foramen Ovale, Patent
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diffusion-weighted Magnetic Resonance Imaging (DW-MRI)Diagnostic test
The Diffusion-weighted Magnetic Resonance Imaging (DW-MRI) is used to diagnose perioperative stroke.
Transcranial Doppler (TCD)Diagnostic test
Used to diagnose PFO
Transthoracic Echocardiogram (TTE)Diagnostic test
Used to diagnose PFO.
| Study group | Role | What they receive |
|---|---|---|
| Surgical patients | Patients undergoing major non-cardiac, non-vascular, and non-brain surgery who will be examined for a presence of PFO Receives: Diagnostic Test: Diffusion-weighted Magnetic Resonance Imaging (DW-MRI); Diagnostic Test: Transcranial Doppler (TCD); Diagnostic Test: Transthoracic Echocardiogram (TTE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of PFO in the target (surgical) population
Identifying PFO status using TCD \& TTE
Measured: Pre-operative
The incidence of perioperative stroke in patients without PFO
Identifying perioperative stroke incidence using DW-MRI
Measured: Within 30 days of surgery
Study enrollment rate
Establishing study enrollment rate and the reasons for refusals to participate
Measured: Pre-operative
Proportion of patients completing the DW-MRI test
Developing mechanisms to successfully arrange the DW-MRI within a short timeframe
Measured: 2-7 days post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2022
- Study start7 Jul 2023
- Primary completion1 Jul 2025 (estimated)
- Study completion1 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Patent Foramen OvaleStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 408 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Peter Munk Cardiac Centre
- Responsible party
- Principal investigator, Eric Horlick, University Health Network, Toronto
- Investigators
- Eric Horlick, MD, Principal investigator, University Health Network, Peter Munk Cardiac CentreLusine Abrahamyan, MD, PhD, Principal investigator, University Health Network, Theta CollaborativeAleksandra Pikula, MD, Principal investigator, University Heath Network, Division of Neurology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05592301
- Sponsor's protocol ID
- 21-5671
- Other IDs
- CAPPRES
- Acronym
- CAPPRES
- Status last verified
- Jul 2023
- First submitted
- 19 Oct 2022
- Last updated
- 17 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hobbes B, Akseer S, Pikula A, Huszti E, Devereaux PJ, Horlick E, Abrahamyan L. Risk of Perioperative Stroke in Patients With Patent Foramen Ovale: A Systematic Review and Meta-analysis. Can J Cardiol. 2022 Aug;38(8):1189-1200. doi: 10.1016/j.cjca.2022.02.026. Epub 2022 Mar 3.
PubMed 35247468
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Canadian Patent Foramen Ovale and Perioperative Stroke Evaluation Study (CAPPRES): A Feasibility Study
- ClinicalTrials.gov ID
- NCT05592301
- Acronym / sponsor ID
- CAPPRES / 21-5671
- Conditions
- Patent Foramen Ovale
- Keywords
- Patent Foramen Ovale, Perioperative Stroke, Diffusion-weighted Magnetic Resonance Imaging
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 408 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Collaborators
- Peter Munk Cardiac Centre
- Study start
- 7 Jul 2023 (actual)
- Primary completion
- 1 Jul 2025 (estimated)
- Study completion
- 1 Jul 2025 (estimated)
- First posted
- 24 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a multi-centre, prospective cohort study to determine if asymptomatic PFO is a risk factor for developing perioperative overt and covert stroke in patients undergoing non-cardiac surgery.
Detailed description
There is emerging evidence regarding the increased risk of perioperative stroke in patients with PFO, leading to an important clinical practice question: whether PFO should be considered in the perioperative risk assessment in non-cardiac surgery patients. The evidence base, however, comes from retrospective studies with numerous limitations.
Patients referred for general, orthopedic, urological, gynecologic, spinal, or thoracic surgery will be screened and consented during the surgery pre-admission clinic visit, and then undergo PFO screening using transcranial Doppler (TCD) and transthoracic echocardiography (TTE). Patients screened PFO+ (n=102) and matched PFO- controls (n=102) will have DW-MRI between postoperative days 2 and 7. Study personnel will conduct phone surveys at 30-day and 1-year post-surgery to collect data on other clinical outcomes. Patients will also be administered cognitive and patient-reported outcome measures assessments before enrollment, and 30-day and 1-year follow-up.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Surgical patients | – | Diagnostic Test: Diffusion-weighted Magnetic Resonance Imaging (DW-MRI), Diagnostic Test: Transcranial Doppler (TCD), Diagnostic Test: Transthoracic Echocardiogram (TTE)Patients undergoing major non-cardiac, non-vascular, and non-brain surgery who will be examined for a presence of PFO |
Who may qualify
- Ages
- 18 to 110 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients referred for an elective, non-cardiac, non-vascular and non-brain surgery
Key inclusion criteria (3 listed)
- patients 18 years and above;
- referred for an elective, non-cardiac, non-vascular and non-brain surgery;
- with an estimated hospital length of stay ≥2 days. We will include patients referred for general, orthopedic, urological, gynecologic, spinal or thoracic surgery.
Key exclusion criteria (4 listed)
- patients in need for long-term, perioperative anticoagulants;
- those with comorbidities that potentially increase the risk of perioperative stroke;
- contraindications to MRI;
- unable to complete or adhere to the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diffusion-weighted Magnetic Resonance Imaging (DW-MRI)The Diffusion-weighted Magnetic Resonance Imaging (DW-MRI) is used to diagnose perioperative stroke. | Diagnostic test | Surgical patients |
| Transcranial Doppler (TCD)Used to diagnose PFO | Diagnostic test | Surgical patients |
| Transthoracic Echocardiogram (TTE)Used to diagnose PFO. | Diagnostic test | Surgical patients |
Primary outcome
Prevalence of PFO in the target (surgical) population
Time frame: Pre-operative
Identifying PFO status using TCD \& TTE
The incidence of perioperative stroke in patients without PFO
Time frame: Within 30 days of surgery
Identifying perioperative stroke incidence using DW-MRI
Study enrollment rate
Time frame: Pre-operative
Establishing study enrollment rate and the reasons for refusals to participate
Proportion of patients completing the DW-MRI test
Time frame: 2-7 days post surgery
Developing mechanisms to successfully arrange the DW-MRI within a short timeframe
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2023.
- Background: PubMed 35247468Hobbes B, Akseer S, Pikula A, Huszti E, Devereaux PJ, Horlick E, Abrahamyan L. Risk of Perioperative Stroke in Patients With Patent Foramen Ovale: A Systematic Review and Meta-analysis. Can J Cardiol. 2022 Aug;38(8):1189-1200. doi: 10.1016/j.cjca.2022.02.026. Epub 2022 Mar 3.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric Horlick, MD principal investigator
University Health Network, Peter Munk Cardiac Centre
Lusine Abrahamyan, MD, PhD principal investigator
University Health Network, Theta Collaborative
Aleksandra Pikula, MD principal investigator
University Heath Network, Division of Neurology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Patent Foramen Ovale, run by University Health Network, Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lusine Abrahamyan, MD, PhD (416-340-4800, lusine.abrahamyan@uhnresearch.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of PFO in the target (surgical) population (time frame: Pre-operative). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05592301, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2023.